The following data is part of a premarket notification filed by Datex-ohmeda, Inc. with the FDA for Datex-ohmeda Tec 7 Anesthesia Vaporizer.
Device ID | K012924 |
510k Number | K012924 |
Device Name: | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER |
Classification | Vaporizer, Anesthesia, Non-heated |
Applicant | DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 -7550 |
Contact | Bill Exner |
Correspondent | Bill Exner DATEX-OHMEDA, INC. P.O. BOX 7550 Madison, WI 53707 -7550 |
Product Code | CAD |
CFR Regulation Number | 868.5880 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2001-08-31 |
Decision Date | 2002-01-30 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00840682111454 | K012924 | 000 |
00840682111324 | K012924 | 000 |
00840682111508 | K012924 | 000 |
00840682111614 | K012924 | 000 |
00840682111744 | K012924 | 000 |
00840682111751 | K012924 | 000 |
00840682111300 | K012924 | 000 |
00840682111003 | K012924 | 000 |
00840682111393 | K012924 | 000 |
00840682111317 | K012924 | 000 |